Interest of Self-compression Technique on Tolerance of Mammography (ITACTs)

• ClinicalTrials.gov Identifier: NCT02866591
• Recruitment Status: Completed
• First Posted: August 15, 2016
• Last Update Posted: August 8, 2018
• Sponsor: Institut de Cancérologie de Lorraine
• Information provided by (Responsible Party): Institut de Cancérologie de Lorraine

Study Description

Brief Summary:

Mammography is used for screening, diagnosis, therapeutic evaluation and monitoring of local cancer breast.

It is sometimes poorly tolerated by some patients who complain of an uncomfortable examination or pain.

Breast compression by the manipulator aims to reduce the thickness of the breast during mammography; This act is an important factor of pain or discomfort felt by the patient. But, it is also an image quality factor.

This study aimed to compare self-breast compression by the patient to the compression standard technique carried out by the manipulator.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Other: mammography according to an auto-compression procedure; Other: mammography according to a standard procedure; Other: questionary	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 550 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Interest of Self-compression Technique on Tolerance of Mammography
• Actual Study Start Date: May 2013
• Actual Primary Completion Date: December 2016
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Arm A; Patients have a mammography performed by themselves according to auto-compression procedure. The radiologist leads the compression at a minimum threshold of 40 Newton, then leaves the control of the compression to the patient. The radiologist treats only the positioning of the breast on the sensor.	Other: mammography according to an auto-compression procedure; Other: questionary
Active Comparator: Arm B; Patients have a mammography performed by the radiologist according to standard procedure.	Other: mammography according to a standard procedure; Other: questionary

Outcome Measures

Primary Outcome Measures :

1. Comparison of two breast compression techniques (auto-compression versus standard procedure) in mammography [ Time Frame: 1 day ]
   The comparison will be evaluated by the thickness (mm) of breast compressed

Secondary Outcome Measures :

1. Overall tolerance of mammography [ Time Frame: 1 day ]
   The overall tolerance of mammography will be assessed by the patient after 4 shots. The pain felt by the patient will be assessed using a visual analog scale.
2. Breast compression force [ Time Frame: 1 day ]
   Value measured on compressive force console (Newtons)
3. Thickness / compressing force ratio [ Time Frame: 1 day ]
4. Image quality [ Time Frame: 1 day ]
   The image quality will be assessed by the radiologist with a quotation of motion blurring on a 4-point scale
5. Overall assessment of the manipulator [ Time Frame: 1 day ]
   The appreciation of the manipulator will be assessed using a 4-point scale
6. Overall assessment of self-satisfaction of the patient at the end of the examination [ Time Frame: 1 day ]
   The measurement of patient satisfaction will be evaluated using a self-administered Norwegian questionnaire (MammoGraphy Questionnaire)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Adult patients ≥ 18 years and ≤ 75 years of age
• ECOG performance <2
• Mammography planned as part of a breast cancer screening or a monitoring following treatment of a breast lesion
• Ability to provide written informed consent
• Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study.

Exclusion Criteria:

• Eastern Cooperative Oncology Group performance status ≥ 2
• Treatment for benign lesion with surgery for less than 3 years
• Treatment for cancer with surgery and / or radiotherapy for less than 3 years
• Biopsy for less than 1 year
• Breast prosthesis
• Mastectomy
• Assessment motivated by a clinical breast abnormality

Contacts and Locations

Locations

France

Institut Bergonié

Bordeaux, France, 33000

Centre François Baclesse

Caen, France, 14076

Cabinet de radiologie

Nancy, France, 54000

Polyclinique Majorelle

Nancy, France, 54000

Institut Curie

Paris, France, 75248

Institut de Cancérologie de Lorraine

Vandoeuvre-les-Nancy, France, 54519

Sponsors and Collaborators

Institut de Cancérologie de Lorraine

Investigators

• Principal Investigator: HENROT Philippe, MD; Institut de Cancérologie de Lorraine

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Henrot P, Boisserie-Lacroix M, Boute V, Troufléau P, Boyer B, Lesanne G, Gillon V, Desandes E, Netter E, Saadate M, Tardivon A, Grentzinger C, Salleron J, Oldrini G. Self-compression Technique vs Standard Compression in Mammography: A Randomized Clinical Trial. JAMA Intern Med. 2019 Mar 1;179(3):407-414. doi: 10.1001/jamainternmed.2018.7169.

• Responsible Party: Institut de Cancérologie de Lorraine
• ClinicalTrials.gov Identifier: NCT02866591
• Other Study ID Numbers: 2012-A00248-35
• First Posted: August 15, 2016
• Last Update Posted: August 8, 2018
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Institut de Cancérologie de Lorraine:

mammography; pain; quality of life; screening; image quality; radiology